Cheese and Human Health

June 8, 2010 updated by: University of Copenhagen

Effects of Hard Cheese and Butter on Markers of Cardiovascular Disease -A Randomized Controlled Dietary Human Intervention

The aim of this study is to examine if a diet rich in cheese will have a beneficial effect on risk markers of cardiovascular disease compared to a diet rich in butter.

The primary parameters are total cholesterol as well as LDL-, HDL cholesterol and triacylglycerol (TAG). The secondary parameters are hsCRP, markers of insulin resistance, fasting insulin and glucose (HOMA). Furthermore bloodpressure is measured.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark
        • Department of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sign written consent
  • Age: 20-70
  • BMI: 20-32
  • Refrain from dietary supplements and blood donations prior to, and during the study

Exclusion Criteria:

  • Known or suspected abuse of alcohol, drugs or medication
  • Poor compliance
  • Current or previously cardiovascular disease
  • Diabetes Mellitus or other severe chronic disease, including severe allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: butter
Danish butter
Other: cheese
the effect of cheese intake versus butter intake on blood lipids (primarily)
Other Names:
  • cheese, butter, dairy
Experimental: cheese
Other: cheese
the effect of cheese intake versus butter intake on blood lipids (primarily)
Other Names:
  • cheese, butter, dairy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HDL cholesterol
Time Frame: 6 weeks
6 weeks
Total cholesterol
Time Frame: 6 weeks
6 weeks
LDL cholesterol
Time Frame: 6 weeks
6 weeks
Triglyceride
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 6 weeks
6 weeks
Insulin
Time Frame: 6 weeks
6 weeks
Glucose
Time Frame: 6 weeks
6 weeks
fasting hsCRP
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

The Danish Dairy Research Foundation, Denmark
National Dairy Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

June 4, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

June 9, 2010

Last Update Submitted That Met QC Criteria

June 8, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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